NDEHP SAPPHIRE MIC NV +0.2FLTR
Received Mar 7, 2024 · Event occurred Feb 1, 2024
Report 9615050-2024-00217 · MDR key 18862904
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical Costa Rica Ltd.Catalog number
163620455
Lot number
5209968
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
NA · Unknown
- Chemical Exposure
- No Clinical Signs, Symptoms or Conditions
- Chemical Exposure
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A NDEHP SAPPHIRE MIC NV +0.2FLTR. IT WAS REPORTED A LEAK OCCURRED FROM ONE OF THE SMALL PERFORATIONS ON THE IN-LINE FILTER. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM-AS PER THE ONCOLOGY PHARMACIST, THE MEDICATION ALSO LEAKED ONTO THE PATIENT'S T-SHIRT, NO SKIN IRRITATION WAS REPORTED. THE PATIENT WAS ADVISED TO THROW THAT T-SHIRT IN THE GARBAGE. THE TEAM WAS WEARING PPE FOR THIS INTERVENTION.
Additional Manufacturer Narrative
THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.